Study name |
Angioplasty and stenting for patients with symptomatic intracranial atherosclerosis |
Methods |
Multicentre randomised trial in 3 high‐volume centres |
Participants |
Estimated sample size: 539 Inclusion criteria
Age 40–70 years
≥ 3 TIAs or 1 ischaemic stroke
70%–99% stenosis of intracranial carotid artery or MCA under maximal dosage of medical management
Cerebral hypoperfusion in the territory of target vessels
Exclusion criteria
CT or MRI evidence of massive cerebral infarction
Cerebral infarction caused by perforator occlusion
Previous stent or angioplasty in the target lesion
Progressive neurological signs within 24 hours before enrolment
Haemorrhagic infarction within 14 days before enrolment
Cardiac source of embolus
Thrombolytic therapy within 24 hours before enrolment
Intraluminal thrombus proximal to or at the target lesion
Myocardial infarction within 30 days before enrolment
Non‐atherosclerotic stenosis
|
Interventions |
PTAS plus aggressive medical management after ≥ 3 weeks versus aggressive medical management alone |
Outcomes |
Primary outcome
Secondary outcomes
Incidence of recurrent ischaemic stroke in the stenting‐involved vascular territory at 30 days, 3 months, and 12 months after randomisation
Rate of participants with residual stenosis < 30% at 3 and 12 months after randomisation
Incidence of in‐stent restenosis at 12 months after randomisation
Incidence of cerebral parenchymal, subarachnoid, or intraventricular haemorrhage at 30 days, 3 months, and 12 months after randomisation
Incidence of myocardial infarction or major non‐stroke haemorrhage (epidural or subdural haemorrhage or haemorrhage in major organs) at 30 days after randomisation
C‐NIHSS: 28; mRS: 29; and CSQoL30 at 30 days, 3 months, and 12 months after randomisation
|
Starting date |
April 2016 |
Contact information |
ClinicalTrials.gov identifier: NCT02689037. More details in the published protocol: DOI: 10.1136/bmjopen‐2016‐012175 |
Notes |
This study is financially supported by a Health Research Fund from People's Liberation Army (No. 12MA100). The study sponsor and funders play no role in study design, collection, management, analysis, and interpretation of data, writing of the report, or the decision to submit the report for publication. |